FDA.reportPublic FDA data

Application 208840

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRANEXAMIC ACIDTRANEXAMIC ACIDINJECTABLE;INJECTION100MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70121-1398Tranexamic AcidTranexamic AcidAmneal Pharmaceuticals LLCANDACurrent
70121-1398Tranexamic AcidTranexamic AcidAmneal Pharmaceuticals LLCANDACurrent
70121-1398Tranexamic AcidTranexamic AcidAmneal Biosciences LLCANDACurrent
70121-1398Tranexamic AcidTranexamic AcidAmneal Pharmaceuticals LLCANDACurrent
70121-1398Tranexamic AcidTranexamic AcidAmneal Pharmaceuticals LLCANDACurrent
70121-1398Tranexamic AcidTranexamic AcidAmneal Pharmaceuticals LLCANDACurrent
70121-1398Tranexamic AcidTranexamic AcidAmneal Pharmaceuticals LLCANDACurrent